Search Filters

Search Results

Found 47 results

510(k) Data Aggregation

    K Number
    K041433
    Device Name
    BRIGHT GOLD XH
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2004-08-19

    (83 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Brite Gold XH alloy intended to be used for onlays, % crowns, crowns and short span bridges PFM crowns
    Device Description
    Bright Gold
    Ask a Question
    K Number
    K040436
    Device Name
    SIMIDUR SUPERIOR
    Manufacturer
    WIELAND DENTAL + TECHNIK GMBH & CO. KG
    Date Cleared
    2004-03-05

    (15 days)

    Product Code
    EJS, ETS
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Simidur Superior is a palladium - silver ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Crowns - Short span bridges - Long span bridges - Removable partials and can be used for - Telescopic and milling work Simidur Superior can be veneered with suitable dental ceramics as well as with dentalcomposites.
    Device Description
    SIMIDUR SUPERIOR is a palladium-silver ceramic alloy with high contents of precious metals (87,0%), intended for dental technicians to fabricate dental restorations. It has an indication for use which ranges from single crowns up to long span bridges with two or more pontics. In addition, it can be used for removable partials as well as for telescopic and milling work. SIMIDUR SUPERIOR is highly corrosion resistant and has aan excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. SIMIDUR SUPERIOR can be veneered with suitable dental ceramics and with dental composites.
    Ask a Question
    K Number
    K022252
    Device Name
    STERNGOLD 1, MODEL 1127781
    Manufacturer
    STERNGOLD
    Date Cleared
    2002-09-19

    (69 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Precious Alloy for use in Crown and Bridge Dental Restorations.
    Device Description
    Stengold 1 is a Yellow Crown and Bridge Alloy.
    Ask a Question
    K Number
    K022469
    Device Name
    ECO E4
    Manufacturer
    WIELAND DENTAL + TECHNIK GMBH & CO. KG
    Date Cleared
    2002-09-18

    (54 days)

    Product Code
    EJS, E12
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Eco E4 is a silver-palladium casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/onlays - Crowns - Short span bridges - Long span bridges Eco E4 can be veneered with suitable dental composites.
    Device Description
    Eco E4 is a high strength silver-palladium casting alloy, intended for dental technicians to fabricate dental restorations. It consists of silver, palladium and gold (93,5%) as well as of copper and zinc. Eco E4 has an indication for use which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics. It complies with the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
    Ask a Question
    K Number
    K021367
    Device Name
    STERNGOLD 66, MODEL #1180230
    Manufacturer
    STERNGOLD
    Date Cleared
    2002-05-16

    (16 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Precious Alloy for use in Crown and Bridge Dental Restorations.
    Device Description
    Sterngold 66 is a White Crown and Bridge Alloy.
    Ask a Question
    K Number
    K020192
    Device Name
    SIMIDUR S2
    Manufacturer
    WIELAND DENTAL + TECHNIK GMBH & CO. KG
    Date Cleared
    2002-03-15

    (52 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Simidur S2 is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Crowns, Short span bridges, Long span bridges, Removable partials and can be used for - Telescopic and milling work. Simidur S2 can be veneered with suitable dental ceramics as well as with dentalcomposites.
    Device Description
    Simidur S2 is a palladium-base ceramic alloy with a high content of noble metals (81% ), intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from single crowns up to long span bridges with two it has an indication which farges wortials. It is free of silver and suitable for telescopic and milling work. Simidur S2 is highly corrosion resistant and has an excellent biocompatibility. It fully Simidal U2 is highly ochooled ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur S2 can be veneered with suitable dental ceramics and with dental composites.
    Ask a Question
    K Number
    K020194
    Device Name
    SIMIDUR KF PLUS
    Manufacturer
    WIELAND DENTAL + TECHNIK GMBH & CO. KG
    Date Cleared
    2002-03-15

    (52 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Simidur KF plus is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work. Simidur KF plus can be veneered with suitable dental ceramics as well as with dentalcomposites.
    Device Description
    Simidur KF plus is a palladium-base ceramic alloy (79,7% Palladium), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from single crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and suitable for telescopic and milling work. Simidur KF plus is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur KF plus can be veneered with suitable dental ceramics and with dental composites.
    Ask a Question
    K Number
    K020195
    Device Name
    SIMIDUR S1S
    Manufacturer
    WIELAND DENTAL + TECHNIK GMBH & CO. KG
    Date Cleared
    2002-03-15

    (52 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Simidur S1S is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Crowns, Short span bridges, Long span bridges, Removable partials and can be used for - Telescopic and milling work. Simidur S1S can be veneered with suitable dental ceramics as well as with dentalcomposites.
    Device Description
    Simidur S1S is a palladium-base ceramic alloy (56,0% Palladium), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from single crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and suitable for telescopic and milling work. Simidur S1S is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur S1S can be veneered with suitable dental ceramics and with dental composites.
    Ask a Question
    K Number
    K014042
    Device Name
    D.SIGN 84
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2002-02-22

    (77 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    d-Sign 84 is intended to be used with conventional feldpathic porcelains. Also a-olgh 04 intended to be assa mas, conus crowns, conus crowns, posts, attachments, short and long span bridges, and PFM crowns.
    Device Description
    Not Found
    Ask a Question
    K Number
    K013809
    Device Name
    D.SIGN 59
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2002-02-07

    (84 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Why did this record match?
    Product Code :

    EJS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    d.SIGN 59 alloy intended to be used for onlay, ¾ crows, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.
    Device Description
    d.SIGN 59 alloy
    Ask a Question

    Page 1 of 5